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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Although many patients share similarities&#44; all patients are different&#46; This seemingly insignificant fact is of paramount importance to understanding the relationship between clinical research and medical practice&#46; Aristotle argued that the observation of multiple individual events could be used to draw general conclusions&#46; This is known as inductive reasoning and is a mainstay of biomedical research&#46; Conclusions for future patients similar to those studied can be established from observing many patients with shared characteristics&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">However&#44; all patients are different&#46; Although two patients suffering from the same disease may present the same signs&#44; symptoms&#44; and identical laboratory tests&#44; they will be two different patients&#46; A patient is more than just his illness&#59; the circumstances&#44; beliefs&#44; values&#44; preferences and goals of the person suffering the disease&#44; and all other elements that differentiate one human being from another mean that no two patients can be exactly alike&#46; These differences form the basis of clinical practice and are the essence of medicine&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">Evidence-based medicine &#40;EBM&#41; and patient-centered medicine &#40;PCM&#41; are two movements that have emerged with great force in health systems in recent years&#46;<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1&#44;2</span></a> While the former has a population approach&#44; and its primary objective is the generalization and improvement of health outcomes in the average patient&#44; PCM has a personalized approach&#44; focusing on individualization and improving health outcomes in specific patients&#46; In a very simplistic way&#44; it could be argued that EBM has its conceptual anchor in research&#44; whereas PCM is anchored in medical care&#46; If the former brings to mind large sample sizes&#44; the latter leads directly to the bed of a patient with a name&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">In 1948&#44; a group of British doctors from the Medical Research Council &#40;MRC&#41;&#44; headed by a physician&#44; D&#8217;Arcy Hart&#44; and a statistician&#44; Bradford Hill &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>&#41;&#44; designed the first modern-age RCT&#44;<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> applying the idea of assigning patients with tuberculosis randomly to each of the two compared treatments&#58; streptomycin and placebo&#46; Random assignment is probably the method that has contributed most to the enormous progress in treatments in the last half-century&#46; The EBM concept emerged in the early 1990s from clinical epidemiology and the significant development of quantitative research and biostatistical methods&#44; establishing the randomized clinical trial &#40;RCT&#41; as the primary reference method&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0025" class="elsevierStylePara elsevierViewall">The RCT has become the cornerstone for evaluating health intervention effectiveness&#44; and is the pillar supporting EBM&#46; Its results show whether&#44; in the average patient&#44; one intervention is better than another&#59; therefore&#44; it serves as the basis for regulatory decisions&#46; But when speaking the language of the population&#44; it moves away from individual patients&#46; Therefore&#44; in the hierarchical classifications proposed by EBM&#44; the observation and study of individual cases rank lowest&#44; whereas experiments with high sample sizes &#40;the higher the better&#41; are at the top&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">Although it is true to say that&#44; defined as a movement&#44; medicine has always been geared toward patients&#44; PCM arises later than EBM&#46; PCM emphasizes the need to look toward the individual patient&#44; understood as a person&#46; Throughout history&#44; there have been many illustrious physicians who have advocated this view&#46; Hippocrates stated that it &#8220;<span class="elsevierStyleItalic">is more important to know which individual is suffering the disease than to know which disease is affecting the individual</span>&#46;&#8221; One of the greatest pioneers of the ideas leading to PCM is the Canadian physician William Osler &#40;<a class="elsevierStyleCrossRef" href="#fig0010">Fig&#46; 2</a>&#41;&#44; who stated &#8220;<span class="elsevierStyleItalic">Variability is the law of life&#44; and as no two faces are the same&#44; so no two bodies are alike&#44; and no two individuals react alike and behave alike under the abnormal conditions which we know as disease&#8230;</span>&#8221; His most famous quote reminds us that &#8220;<span class="elsevierStyleItalic">If it were not for the great variability among individuals&#44; medicine might as well be a science and not an art</span>&#46;&#8221;</p><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0035" class="elsevierStylePara elsevierViewall">By focusing on heterogeneity and personalized care&#44; PCM &#8220;tries to provide the best health care to every patient&#44; under the conditions of clinical practice&#44; taking into account their objectives&#44; preferences and values as well as available economic resources&#46;&#8221;<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a></p><p id="par0040" class="elsevierStylePara elsevierViewall">Although the concept of personalized medicine suggests almost immediately the genome and double helix image&#44; it should be noted that the personalization to which PCM refers goes well beyond genes&#46; Concepts such as <span class="elsevierStyleItalic">shared decision making</span><a class="elsevierStyleCrossRefs" href="#bib0025"><span class="elsevierStyleSup">5&#44;6</span></a> and <span class="elsevierStyleItalic">patient empowerment</span> are essential to understanding the scope of this new trend&#46; Personalization has much to do with the physician&#39;s efforts to better understand the psychological&#44; cultural and social aspects that determine each patient&#39;s attitude to the disease&#59; these are factors that significantly affect the prognosis&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">Because of their distinctive features&#44; one might think that EBM and PCM are two antagonistic movements&#46; After all&#44; there is a gap between them comparable to that of science and art&#44; experiment and observation&#44; populations and individuals&#44; research and medical practice&#44; but nothing is further from reality&#46; As epidemiologist Alvan R&#46; Feinstein noted&#44; any research or clinical activity begins at the patient&#39;s bedside and each medical act has the structure of an experiment&#46;<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a></p><p id="par0050" class="elsevierStylePara elsevierViewall">The perception that these are two independent movements may stem from the fact that clinical research&#44; due to its growing sophistication and professionalism&#44; has been increasingly separating from medicine&#46; In clinical research&#44; a physician&#8211;researcher treats a &#8220;study subject&#8221; in order to generate useful knowledge for future patients&#46; In clinical practice&#44; the physician&#39;s goal is to provide the best treatment for the patient&#46; The physician is faced with an ethical conflict in his dual role of clinician and researcher&#44;<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a> and this has yet to be resolved satisfactorily&#46; Although the scope of this paper does not allow for further examination of the issue&#44; it suffices to say that in many cases&#44; this ethical conflict need not occur&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">The profound changes that are currently taking place in health systems can facilitate the confluence of EBM and PCM&#44; i&#46;e&#46;&#44; research and health care&#46; Some of these changes include the development of information technology&#44; especially electronic medical records and decision-making support systems&#59; the growing interest in evaluating the effectiveness of interventions in the conditions of clinical practice and the emergence of comparative effectiveness research&#59; more systematic measurements of <span class="elsevierStyleItalic">Patient Reported Outcomes</span> &#40;PRO&#41;<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a>&#59; regulatory changes aimed at continuous assessment of the risk-benefit of interventions throughout the life cycle&#59; the development and standardization of clinical and therapeutic guidelines&#59; the practice of more defensive medicine&#59; advances in the area of genomics or the development of increasingly accurate risk prediction models&#59; and new statistical methods designed to analyze the heterogeneity in the response of various subgroups of patients&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">Some signs point to research and medicine meeting again soon&#46; The scientific community is beginning to ask why all the knowledge generated in the millions of medical procedures that take place every day is not being used&#44; and why only a small part of the knowledge generated from research results is applied&#46; What is the benefit of expanding the selection criteria of the RCTs so much&#63; What will become of the role of randomization when genomic advances can predict the response to different treatments&#63; What is the point of speaking about averages in the case of preferences&#44; or why does the population approach in research produce better health outcomes than the individual approach&#44; i&#46;e&#46;&#44; why do we &#8220;settle&#8221; for just knowing that in the average patient intervention A is better than intervention B&#44; if we can identify for which patients each is better&#63;</p><p id="par0065" class="elsevierStylePara elsevierViewall">The challenge is how to bring the two movements together&#46; To achieve this goal&#44; EBM and PCM should adjust their traditional reference points and find common ground&#46; Research methods should approach the individual patient and medical practice should approach future patients&#44; so that both EBM and PCM can help generate knowledge and improve health outcomes for patients today and tomorrow&#46; Sometimes one needs to look back at the origins&#44; avoid dogmatism and learn from the pioneers&#46; As noted by Dr&#46; Crofton&#44; a member of the MRC who participated in the first clinical trial&#44;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> &#8220;&#46;&#46;&#46;<span class="elsevierStyleItalic">Randomized trials were not intellectually stimulating&#46; Our greatest intellectual challenge with tuberculosis research was to identify the reasons why the treatment failed&#46; The results of randomized trials&#44; together with detailed investigation of drug resistance in individual patients and the appropriate organization of services&#44; allowed our team to reach one hundred percent recovery from pulmonary tuberculosis&#44; the most common form of the disease and one that not long ago killed half of the patients who suffered from it</span>&#46;&#8221;</p><p id="par0070" class="elsevierStylePara elsevierViewall">A patient-centered approach requires investigation to develop truly &#8220;patient-oriented research&#44;&#8221; whose aim is to identify the best option for each patient &#40;also taking into account his&#47;her preferences and other relevant variables relevant&#41;&#44; to individualize the results of research&#44; to try to determine efficacy in subgroups and individuals&#44; to apply a hypothetical-deductive logic &#40;testing of theories from individual observations&#41;&#44; to consider that experiments are exploratory and observations are confirmatory&#44; and to be based on the analysis of heterogeneity and differences&#46;<a class="elsevierStyleCrossRefs" href="#bib0055"><span class="elsevierStyleSup">11&#44;12</span></a> Obviously&#44; RCT cannot be the only paradigm of this patient-oriented research&#46; Currently&#44; new research strategies are being developed that focus on the analysis of heterogeneity&#44;<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">13</span></a> and the enormous potential of <span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>1 trials or crossover studies are being rediscovered to analyze individual responses&#46;</p><p id="par0075" class="elsevierStylePara elsevierViewall">Approaching future patients requires medical practice to become a suitable environment for research&#44; so as to make better use of all the knowledge that is generated in each medical act&#46; This is what might be called &#8220;medicine-based evidence&#46;&#8221;<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">14</span></a> This should be achieved not only by providing observational studies and integrating pragmatic clinical trials into clinical practice&#44;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">15</span></a> but also by rediscovering the value of observations on individual cases&#46; An unexpected response&#44; the occurrence of an adverse effect&#44; or the need for an abnormally high dose is useful information for not only one specific patient &#40;at this time and in the future&#41; but also for future patients&#46; Unexpected cases &#40;or &#8220;anomalies&#8221;&#41; are fundamental to refute assumptions and open up new paths for research&#46; Some authors have called &#8220;level IV evidence&#8221; that which comes from individual cases&#46;<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">16</span></a> These are the &#8220;adverse anecdotes&#44;&#8221;<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">17</span></a> which unlike what usually happens with RCTs&#44; change clinical practice in an instant&#46; No doubt electronic medical records can facilitate the integration of research into medicine&#46;</p><p id="par0080" class="elsevierStylePara elsevierViewall">Furthermore&#44; it is noteworthy that careful observation of patients has been and will be central to the process of clinical research&#44; as Khun&#39;s description suggests on the discovery of the first antidepressant&#58;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">18</span></a> &#8220;<span class="elsevierStyleItalic">I&#8217;ve never used &#8216;double-blind&#44; controlled studies&#8217; versus placebo&#44; standardized rating scales&#44; or statistical treatment of data from a large number of patients&#46; Instead&#44; I examined each patient individually every day&#44; often several times&#44; and asked them questions over and over&#46; Many of my patients were also under the observation of my assistants and nurses&#44; and I always took their suggestions and criticisms very seriously</span>&#46;&#8221;</p><p id="par0085" class="elsevierStylePara elsevierViewall">The focus on the patient is a great opportunity to bring together research and medical practice&#44; the worlds of EBM and PCM &#40;<a class="elsevierStyleCrossRef" href="#fig0015">Fig&#46; 3</a>&#41;&#46; The study of similarities and inductive reasoning is at the forefront of EBM&#44; the path that goes from the individual patient to the average patient&#46; However&#44; we must complete that circle with new research strategies&#44; based on the analysis of differences&#44; going from the average patient to the individual patient&#46;<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a> EBM and PCM&#44; like research and medical practice&#44; are two sides of the same coin&#44; which should complement and aid each other&#46; It is difficult to see how one can reach its full potential without the other as a continual reference&#46; PCM should not be practiced without being based on the best available evidence&#44; and it is impossible to imagine an EBM whose ultimate goal is disconnected from the individual patient&#46;</p><elsevierMultimedia ident="fig0015"></elsevierMultimedia><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conflicts of interest</span><p id="par0090" class="elsevierStylePara elsevierViewall">The author states that he is an employee of Lilly Spain&#46; The opinions and ideas expressed in this article are personal and do not necessarily represent those of the company&#46;</p></span></span>"
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            0 => "Evidence based medicine"
            1 => "Medicine"
            2 => "Patient"
            3 => "Clinical trials"
            4 => "Research"
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            0 => "Medicina basada en la evidencia"
            1 => "Medicina"
            2 => "Paciente"
            3 => "Ensayos cl&#237;nicos"
            4 => "Investigaci&#243;n"
            5 => "Pr&#225;ctica m&#233;dica"
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        "titulo" => "Abstract"
        "resumen" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Evidence-based medicine &#40;EBM&#41; and patient-centered medicine &#40;PCM&#41; are two movements that have emerged with great force in health systems in recent years&#46; EBM has a population approach&#44; and its primary objective is the generalization and improvement of health outcomes in the average patient&#46; PCM has a personalized approach&#44; focuses on individualization and improving health outcomes in specific patients&#46; While EBM has its conceptual anchor in research&#44; PCM has it in medical care&#46;</p><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Despite EBM and PCM being perceived as conflicting movements&#44; the profound changes that are currently taking place in health systems can facilitate the confluence of clinical research and medical care&#46; This article constitutes a reflection on how research methods should approach the individual patient and medical practice should approach future patients&#46; EBM and PCM&#44; like research and medical practice&#44; are two sides of the same coin&#44; which should complement and aid each other&#46; It is difficult to see how one of them can reach its full potential without the other as a continual reference&#44; because PCM should not be practiced without being based on the best available evidence and it is impossible to imagine an EBM whose ultimate goal is disconnected from the individual patient&#46;</p>"
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        "titulo" => "Resumen"
        "resumen" => "<p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">La medicina basada en la evidencia &#40;MBE&#41; y la medicina centrada en el paciente &#40;MCP&#41; son dos corrientes que han surgido con fuerza en los sistemas sanitarios en los &#250;ltimos a&#241;os&#46; La MBE tiene un enfoque poblacional y su objetivo primordial es la generalizaci&#243;n y la mejora de los resultados sanitarios en el promedio de los pacientes&#46; La MCP tiene un enfoque individual&#44; busca la particularizaci&#243;n y la mejora de los resultados sanitarios en los pacientes individuales&#46; Mientras que el anclaje conceptual de la MBE es la investigaci&#243;n&#44; el de la MCP es el cuidado m&#233;dico&#46;</p><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">A pesar de que MBE y MCP puedan parecer corrientes antag&#243;nicas&#44; los profundos cambios que est&#225;n teniendo lugar en los sistemas sanitarios&#44; pueden facilitar el progresivo &#171;reencuentro&#187; de la investigaci&#243;n y la pr&#225;ctica cl&#237;nica&#46; El presente art&#237;culo constituye una reflexi&#243;n sobre c&#243;mo los m&#233;todos de investigaci&#243;n deber&#237;an acercarse al paciente individual y la pr&#225;ctica m&#233;dica deber&#237;a acercarse a los futuros pacientes&#46; La MBE y la MCP&#44; al igual que la investigaci&#243;n y la pr&#225;ctica m&#233;dica&#44; son las dos caras de la misma moneda&#44; que deber&#237;an complementarse y nutrirse mutuamente&#46; Es dif&#237;cil entender que una de ellas pueda alcanzar todo su potencial sin tener a la otra como continua referencia&#46; Porque no deber&#237;a practicarse una MCP que no estuviese basada en la mejor evidencia disponible&#44; ni es posible imaginar una MBE cuyo objetivo final este alejado del paciente individual&#46;</p>"
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        "etiqueta" => "&#9734;"
        "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as&#58; Sacrist&#225;n JA&#46; Medicina basada en la evidencia y medicina centrada en el paciente&#58; algunas reflexiones sobre su integraci&#243;n&#46; Rev Clin Esp&#46; 2013&#59;213&#58;460&#8211;464&#46;</p>"
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          "en" => "<p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">D&#8217;Arcy Hart and Bradford Hill&#44; &#8220;Fathers&#8221; of the first clinical trial of the modern age&#46; Completar con el copyrigth de las figuras&#58;&#40;&#169; Nick Sinclair y James Lind Library&#41;&#46;</p>"
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          "en" => "<p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">William Osler&#44; pioneer of patient-centered medicine&#46;</p>"
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Journal Information
Vol. 213. Issue 9.
Pages 460-464 (December 2013)
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Vol. 213. Issue 9.
Pages 460-464 (December 2013)
Humanities in Medicine
Evidence based medicine and patient centered medicine: Some thoughts on their integration
Medicina basada en la evidencia y medicina centrada en el paciente: algunas reflexiones sobre su integración
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J.A. Sacristán
Departamento Médico, Lilly España, Alcobendas, Madrid, Spain
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Abstract

Evidence-based medicine (EBM) and patient-centered medicine (PCM) are two movements that have emerged with great force in health systems in recent years. EBM has a population approach, and its primary objective is the generalization and improvement of health outcomes in the average patient. PCM has a personalized approach, focuses on individualization and improving health outcomes in specific patients. While EBM has its conceptual anchor in research, PCM has it in medical care.

Despite EBM and PCM being perceived as conflicting movements, the profound changes that are currently taking place in health systems can facilitate the confluence of clinical research and medical care. This article constitutes a reflection on how research methods should approach the individual patient and medical practice should approach future patients. EBM and PCM, like research and medical practice, are two sides of the same coin, which should complement and aid each other. It is difficult to see how one of them can reach its full potential without the other as a continual reference, because PCM should not be practiced without being based on the best available evidence and it is impossible to imagine an EBM whose ultimate goal is disconnected from the individual patient.

Keywords:
Evidence based medicine
Medicine
Patient
Clinical trials
Research
Medical practice
Resumen

La medicina basada en la evidencia (MBE) y la medicina centrada en el paciente (MCP) son dos corrientes que han surgido con fuerza en los sistemas sanitarios en los últimos años. La MBE tiene un enfoque poblacional y su objetivo primordial es la generalización y la mejora de los resultados sanitarios en el promedio de los pacientes. La MCP tiene un enfoque individual, busca la particularización y la mejora de los resultados sanitarios en los pacientes individuales. Mientras que el anclaje conceptual de la MBE es la investigación, el de la MCP es el cuidado médico.

A pesar de que MBE y MCP puedan parecer corrientes antagónicas, los profundos cambios que están teniendo lugar en los sistemas sanitarios, pueden facilitar el progresivo «reencuentro» de la investigación y la práctica clínica. El presente artículo constituye una reflexión sobre cómo los métodos de investigación deberían acercarse al paciente individual y la práctica médica debería acercarse a los futuros pacientes. La MBE y la MCP, al igual que la investigación y la práctica médica, son las dos caras de la misma moneda, que deberían complementarse y nutrirse mutuamente. Es difícil entender que una de ellas pueda alcanzar todo su potencial sin tener a la otra como continua referencia. Porque no debería practicarse una MCP que no estuviese basada en la mejor evidencia disponible, ni es posible imaginar una MBE cuyo objetivo final este alejado del paciente individual.

Palabras clave:
Medicina basada en la evidencia
Medicina
Paciente
Ensayos clínicos
Investigación
Práctica médica

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